LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer

NCT04053062 | Suspended Phase 1

• 1 other identifier: 2020-CAR-00CH1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, single arm Phase I study to establish the safety and efficacy of intravenously administered lentivirally transduced LIGHT-PSMA-specific CAR modified autologous T cells (PSMA-CART cells) in patients with CRPC.

Conditions

Castrate-Resistant Prostate Cancer

Keywords

Castrate-Resistant

Outcome Measures

Primary Outcomes (1)

• Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

  All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.

  28 days

Secondary Outcomes (3)

• PSA response rate

  24 weeks

• Radiographic response rate by RECIST 1.1 & PCWG3.

  24 weeks

• Duration time of CART cells in vivo

  24 weeks

Study Arms (1)

LIGHT-PSMA-CART

EXPERIMENTAL

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -6 to -4. Patients receive LIGH-PSMA-CART IV at split doses from day 0 on.

Biological: LIGHT-PSMA-CART cells

Interventions

LIGHT-PSMA-CART cells BIOLOGICAL

LIGHT-PSMA-CART cells will be given IV at split doses

Also known as: Autologous PSMA-specific chimeric antigen cells co-expressing LIGHT

LIGHT-PSMA-CART

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand and voluntarily sign informed consent.
• Male, aged 18 to 75 years old.
• Expected survival \> 6 months.
• CRPC patients: Prostate cancer is still progressing after continuous androgen deprivation therapy. Including, castrate levels of serum testosterone (\<50ng/dl or \<1.7nmol/L); or prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, and PSA\>1 ug/L; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
• CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastasis).
• Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%.
• ECOG score \<2.
• Hgb \> 10 g/dl.
• PLT \> 100×109/L.
• ANC \> 1.5×109/L.

You may not qualify if:

• Prior treatment with any immunotherapy, including CART therapy, tumor vaccine therapy, radium-223, checkpoint inhibitors.
• Prior treatment with any PSMA targeting therapy.
• Subjects with severe mental disorders.
• Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (LVEF \< 55%) was decreased by echocardiography or MUGA scan (within 8 weeks before PBMC collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis.
• Patients with ongoing or active infection.
• Aspartate aminotransferase or Alanine aminotransferase \>2.5\*ULN; CK\>1.5\*ULN; CK-MB\>1.5\*ULN; TnT\>1.5\*ULN.
• Total bilirubin \>1.5\*ULN.
• Partial prothrombin time or activated partial thromboplastin time or international standardized ratio \> 1.5\*ULN without anticoagulant treatment.
• History of participation in other clinical studies within 3 months or treatment with any gene therapy product.
• Intolerant or allergic to cyclophosphamide or fludarabine.
• Subjects not appropriate to participate in this clinical study judged by investigators.

Sponsors & Collaborators

• Bioray Laboratories: lead
• Changhai Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Study Officials

• Shancheng Ren, Professor

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 x 10\^6/ KgBW; 6 x 10\^6/ KgBW

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Study Start: July 16, 2020
• Primary Completion: May 15, 2022
• Study Completion: October 15, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

CN (1)